Challenges and solutions for recruiting pregnant smokers into a nicotine replacement therapy trial Kathryn I. Pollak, Cheryl A. Oncken, Isaac M. Lipkus, Bercedis L. Peterson, Geeta K. Swamy, Pamela K. Pletsch, Pauline Lyna, Rebecca J. Namenek Brouwer, Laura J. Fish, Evan R. Myers [Received 4 February 2005; accepted 31 October 2005] Improvements in smoking cessation interventions for pregnant smokers are needed. One major step is to examine the potential effectiveness of nicotine replacement therapy (NRT). The potential benefits of providing pregnant women with NRT to help them quit smoking are still unknown; early interventions to test the effectiveness and efficacy are vital to advancing the field. This paper describes recruitment efforts for a multiclinic trial to test the effectiveness of NRT use in addition to behavioral therapy in promoting cessation during pregnancy. The biggest challenge is recruiting sufficient numbers of pregnant women. This paper discusses specific obstacles for recruitment and solutions. Knowing the potential pitfalls to recruiting pregnant women into these trials can lead to better studies and thus improved outcomes. Introduction Substantial data indicate that smoking during preg- nancy is related to numerous adverse pregnancy outcomes including miscarriage, stillbirth, placenta previa, placental abruption, low birth weight, and cognitive impairments (Cliver et al., 1995; DiFranza & Lew, 1995; Goldenberg et al., 1993; Haglund & Cnattingius, 1990). Most pregnant smokers want to quit smoking and prefer individualized smoking cessation behavioral interventions (Ussher, West, & Hibbs, 2004). Indeed, many behavioral smoking cessation interventions have been developed for pregnant smokers (Colby et al., 1998; Floyd, Rimer, Giovino, Mullen, & Sullivan, 1993; Glasgow, Whitlock, Eakin, & Lichtenstein, 2000; Hartmann, Thorp, Pahel-Short, & Koch, 1996; Kendrick et al., 1995; McBride et al., 1999; Pletsch, 2002; Sexton & Hebel, 1984; Stotts, DeLaune, Schmitz, & Grabowski, 2004; Stotts, DiClemente, & Dolan-Mullen, 2002; Valanis et al., 2001). However, these interventions have proven less effective among women who have a partner who smokes, among those who are less educated, and among heavier smokers (more than 10 cigarettes/day; Adams et al., 1992; Ershoff, Mullen, & Quinn, 1989; Frost et al., 1994; Kendrick et al., 1995; McBride et al., 1999; O’Campo, Faden, Brown, & Gielen, 1992). Nicotine dependence may play a role in a pregnant woman’s inability to quit. Pharmacotherapies have been shown to be effective in nicotine-dependent nonpregnant populations; consequently, there is substantial interest in the potential role of nicotine replacement therapy (NRT) among nicotine- dependent pregnant smokers (Coleman, Britton, & Thornton, 2004; Dempsey & Benowitz, 2001). ISSN 1462-2203 print/ISSN 1469-994X online # 2006 Society for Research on Nicotine and Tobacco DOI: 10.1080/14622200600789882 Baby Steps Team: Kathryn I. Pollak, Ph.D., Duke Comprehensive Cancer Center, Cancer Prevention, Detection and Control Research Program and Department of Community and Family Medicine; Isaac M. Lipkus, Ph.D., Duke Comprehensive Cancer Center, Cancer Prevention, Detection and Control Research Program and the Department of Psychiatry; Bercedis L. Peterson, Ph.D., Department of Biostatistics; Geeta K. Swamy, M.D., Department of Obstetrics and Gynecology; Pauline Lyna, M.P.H., Rebecca J. Namenek Brouwer, M.S., Laura J. Fish, M.P.H., Duke Comprehensive Cancer Center, Cancer Prevention, Detection and Control Research Program; Evan R. Myers, M.D., M.P.H., Duke Comprehensive Cancer Center, Cancer Prevention, Detection and Control Research Program and the Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC; Cheryl A. Oncken, M.D., Department of Medicine, University of Connecticut Health Center, Farmington, CT; Pamela K. Pletsch, Ph.D., R.N., School of Nursing, University of North Carolina, Chapel Hill, NC. Correspondence: Kathryn I. Pollak, Ph.D., Duke Comprehensive Cancer Center, Cancer Prevention, Detection and Control Research Program, Suite 602, Room 6029, Hock Plaza I, 2424 Erwin Road, Durham, NC 27705, USA. Tel: +1 (919) 681-4757; Fax: +1 (919) 681- 4785; E-mail: kathryn.pollak@duke.edu Nicotine & Tobacco Research Volume 8, Number 4 (August 2006) 547–554